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Strength Training in Walking Tolerance in Intermittent Claudication Patients

Primary Purpose

Peripheral Arterial Disease, Hypertension, Diabetes

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Walking Training
Strength Training
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring peripheral arterial disease, exercise, resistance training, cardiac rehabilitation

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Fontaine stage II peripheral arterial disease(14)
  • Symptoms of intermittent claudication for at least 6 months
  • Ankle/brachial index (ABI) at rest ≤ 0.90 in 1 or 2 legs
  • Reduction of ABI after treadmill test
  • Exercise tolerance limited by intermittent claudication

Exclusion Criteria:

  • Presence of chronic lung disease
  • Inability to obtain ABI measurement due to noncompressible vessels
  • Exercise tolerance limited by factors other than claudication (e.g., dyspnea or orthopedic problems)
  • Poorly controlled blood pressure
  • Presence of electrocardiogram response suggestive of myocardial ischemia during the exercise test
  • History of revascularization in the previous year

Sites / Locations

  • Raphael Dias

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Strength training

Walking training

Arm Description

Patients who performed strength training. The strength training program was composed by 8 exercises for whole body performed at sub-maximal intensity prescribed according to the patients self-perceived effort

Patients who performed walking training. The walking training was performed in a treadmill using sub-maximal intensity prescribed based in patients self perceived effort

Outcomes

Primary Outcome Measures

Total Walking Distance
The maximal walking distance

Secondary Outcome Measures

Full Information

First Posted
January 27, 2009
Last Updated
October 24, 2016
Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT00879697
Brief Title
Strength Training in Walking Tolerance in Intermittent Claudication Patients
Official Title
Effects of Strength Training and Walking Training on Physical Fitness of Patients With Intermittent Claudication
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Background: Muscle atrophy and reduced leg strength are related to exercise intolerance in patients with intermittent claudication (IC), suggesting that strength training (ST) could improve exercise performance in these patients. Objective: Analyze the effects of ST in walking capacity in patients with IC comparing with walking training (WT) effects. Intervention: Patients were randomized into ST and WT. Both groups trained twice a week, for 12 weeks, at the same rate of perceived exertion. ST consisted of 3 sets of 10 repetitions of whole body exercises. WT consisted of 15 two-minute bouts of walking intercalated with 2 minutes of resting. Measurements: Walking capacity, peak VO2, walking economy, ankle brachial index, ischemic window and knee extension strength
Detailed Description
From July 2005 to December 2006, three hundred patients with peripheral arterial disease, who were enrolled in a tertiary center specialized in vascular disease and were able to walk for at least 2 minutes at 2 miles per hour, were invited to a meeting at which explanations about this study were given. 80 patients attended the meeting, 60 of them decided to take part of the study, and 52 attended for the screening tests. Patients were included in the study if they met the following criteria: Fontaine stage II peripheral arterial disease, symptoms of IC for at least 6 months, ankle/brachial index (ABI) at rest ≤ 0.90 in 1 or 2 legs, reduction of ABI after treadmill test, and exercise tolerance limited by IC. Patients were excluded under the following conditions: presence of chronic lung disease, inability to obtain ABI measurement due to noncompressible vessels, exercise tolerance limited by factors other than claudication (eg, dyspnea or orthopedic problems), poorly controlled blood pressure, presence of electrocardiogram response suggestive of myocardial ischemia during the exercise test, and history of revascularization in the previous year. Procedures Patients were randomly (by drawing lots) divided into 2 groups: strength (ST, n = 17) and walking (WT, n = 17) training. They were evaluated at baseline (pre-training) and after 12 weeks of exercise training (post-training). During evaluations were assessed exercise tolerance and strength. Both training programs (ST and WT) were supervised, conducted twice a week, lasted for 12 weeks, and started after a 2-week preconditioning-orientation phase. In both programs, rate of perceived exertion during exercise was kept similar and between 11 to 13 on the15-grade Borg scale. Furthermore, the duration of exercise sessions was prescribed as 30 min of exercise for ST and WT groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease, Hypertension, Diabetes
Keywords
peripheral arterial disease, exercise, resistance training, cardiac rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Strength training
Arm Type
Active Comparator
Arm Description
Patients who performed strength training. The strength training program was composed by 8 exercises for whole body performed at sub-maximal intensity prescribed according to the patients self-perceived effort
Arm Title
Walking training
Arm Type
Active Comparator
Arm Description
Patients who performed walking training. The walking training was performed in a treadmill using sub-maximal intensity prescribed based in patients self perceived effort
Intervention Type
Behavioral
Intervention Name(s)
Walking Training
Other Intervention Name(s)
Walk training, Walk exercise
Intervention Description
The Walking Training program was performed using a treadmill. In each session, patients performed fifteen 2-min bouts of exercise followed by a 2-min rest interval, as previously described. Walking speed was set in order to induce perceived exertion of 11 to 13 and claudication pain in the last 30 seconds of each exercise bout.
Intervention Type
Behavioral
Intervention Name(s)
Strength Training
Other Intervention Name(s)
Resistance training, Weight training
Intervention Description
The strength training program consisted of 8 exercises (leg press, crunches, unilateral knee extension, seated row, unilateral knee flexion, seated bench press, calf raises on leg press, and seated back extension). In each exercise, subjects performed 3 sets of 10 repetitions with a 2-min interval between sets and exercises.
Primary Outcome Measure Information:
Title
Total Walking Distance
Description
The maximal walking distance
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Fontaine stage II peripheral arterial disease(14) Symptoms of intermittent claudication for at least 6 months Ankle/brachial index (ABI) at rest ≤ 0.90 in 1 or 2 legs Reduction of ABI after treadmill test Exercise tolerance limited by intermittent claudication Exclusion Criteria: Presence of chronic lung disease Inability to obtain ABI measurement due to noncompressible vessels Exercise tolerance limited by factors other than claudication (e.g., dyspnea or orthopedic problems) Poorly controlled blood pressure Presence of electrocardiogram response suggestive of myocardial ischemia during the exercise test History of revascularization in the previous year
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria FN Marucci, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Raphael Dias
City
São Paulo
ZIP/Postal Code
05588000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18784409
Citation
Dias RM, Forjaz CL, Cucato GG, Costa LA, Camara LC, Wolosker N, Marucci Mde F. Obesity decreases time to claudication and delays post-exercise hemodynamic recovery in elderly peripheral arterial disease patients. Gerontology. 2009;55(1):21-6. doi: 10.1159/000155219. Epub 2008 Sep 11.
Results Reference
result
PubMed Identifier
21948782
Citation
Grizzo Cucato G, de Moraes Forjaz CL, Kanegusuku H, da Rocha Chehuen M, Riani Costa LA, Wolosker N, Kalil Filho R, de Fatima Nunes Marucci M, Mendes Ritti-Dias R. Effects of walking and strength training on resting and exercise cardiovascular responses in patients with intermittent claudication. Vasa. 2011 Sep;40(5):390-7. doi: 10.1024/0301-1526/a000136.
Results Reference
derived
PubMed Identifier
19837534
Citation
Ritti-Dias RM, Wolosker N, de Moraes Forjaz CL, Carvalho CR, Cucato GG, Leao PP, de Fatima Nunes Marucci M. Strength training increases walking tolerance in intermittent claudication patients: randomized trial. J Vasc Surg. 2010 Jan;51(1):89-95. doi: 10.1016/j.jvs.2009.07.118. Epub 2009 Oct 17.
Results Reference
derived

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Strength Training in Walking Tolerance in Intermittent Claudication Patients

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